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Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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At the conclusion of the investigation, it was determined that the cause of the misinterpretation was poor quality data.The cause of the data issue could not be established.The report provided does not provide diagnosis; rather it provides preliminary findings from which the clinician may make a diagnosis based on clinical judgement and patient clinical history.
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Event Description
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An ecg result was provided to the physician with incorrect information.As a result, the patient was recommended treatment on the incorrect finding.Information regarding patient impact and if patient received treatment was not provided.
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Search Alerts/Recalls
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